RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Celecoxib may slow the growth of cancer by stopping blood flow to the tumor. Combining gefitinib with celecoxib may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining gefitinib with celecoxib in treating patients who have non-small cell lung cancer that is refractory to platinum-based chemotherapy (such as cisplatin or carboplatin).

Determine the progression-free and overall survival of patients treated with this regimen.

Determine the toxicity of this regimen in these patients.

OUTLINE: Patients receive oral gefitinib once daily and oral celecoxib twice daily on days 1-28. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed for up to 6 weeks.

PROJECTED ACCRUAL: A total of 18-27 patients will be accrued for this study within 22 months.

AST/ALT no greater than 2.5 times ULN (if alkaline phosphatase is no greater than ULN)

Alkaline phosphatase no greater than 5 times ULN (if AST and ALT are greater than ULN)

No history of chronic hepatitis

Renal

Creatinine no greater than 1.5 times ULN

Cardiovascular

No active thromboembolic event within the past 4 weeks

No uncontrolled congestive heart failure

No uncontrolled angina

No myocardial infarction and/or stroke within the past 6 months

Pulmonary

No evidence of clinically active interstitial lung disease

Gastrointestinal

No history of gastrointestinal bleeding within the past 6 months

No history of peptic ulcer disease

Other

Not pregnant or nursing

Negative pregnancy test

Fertile patients must use effective contraception

Must weigh at least 110 pounds (50 kg)

HIV negative

No allergy to sulfonamides

No allergy to any NSAID, including celecoxib

No known severe hypersensitivity to gefitinib or any of its excipients

No other malignancy within the past 3 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

No history of dementia, active psychiatric disorder, or any other condition that would preclude study compliance

No other concurrent serious medical condition

PRIOR CONCURRENT THERAPY:

Biologic therapy

No prior epidermal growth factor receptor inhibitor

No concurrent biologic therapy

Chemotherapy

See Disease Characteristics

More than 2 weeks since prior chemotherapy

Endocrine therapy

Not specified

Radiotherapy

Recovered from prior radiotherapy

Surgery

Recovered from prior surgery

Other

Recovered from prior therapy

More than 2 weeks since prior investigational therapy

More than 1 week since prior fluconazole

More than 30 days since prior participation in another investigational agent clinical trial

More than 30 days since prior chronic nonsteroidal anti-inflammatory drugs (NSAIDs), including celecoxib or rofecoxib

No prior gefitinib

No prior cyclooxygenase-2 (COX-2) inhibitor or another clinical trial for NSCLC

No other concurrent NSAIDs

Concurrent aspirin allowed (not to exceed 325 mg/day)

No other concurrent COX-2 inhibitors

No concurrent lithium

No concurrent fluconazole

No concurrent use of any of the following:

Phenytoin

Carbamazepine

Barbiturates

Rifampin

Phenobarbital

Hypericum perforatum

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00068653